Morbid obesity remains an ever-growing problem in the U.S. Varying forms of gastric bypass surgery have developed and have improved over the last few decades. Recently, laparoscopic gastric banding has emerged as a less invasive surgical option. However, bariatric surgery is fraught with morbidity of up to 20%, with a re-operation rate approaching 25% at 3-5 years post-op. Bariatric surgery carries an operative mortality of 0.5%. Diet and pharmaceutical alternatives have not been very effective, with a high recidivism rate. Today, the Bioenterics® intragastric balloon (BIB®) (Inamed Corporation, Santa Barbara, Calif., USA) is in use outside of the U.S., achieving average weight loss of 15 kg and 5 point drop in BMI. However, an 8-9% balloon deflation rate has resulted in unwarranted migration leading to obstruction.
US Patent Application Publication 2004/0044357 to Gannoe et al., which is incorporated herein by reference, describes gastric space occupying devices that include a stent configured for deployment in the gastrointestinal tract of a patient, and in particular, for deployment in the esophagus or the stomach. Secured to the stent is an expandable member that is adapted to reside within the patient's stomach. When expanded, the expandable member occupies a predefined volume within the patient's stomach and is further tethered to the deployed stent, thereby retaining or anchoring the expandable member within the stomach. Methods and systems for the deploying the space occupying devices are also described.
PCT Publication WO 05/107641, US Patent Application Publication 2005/0267596, and US Patent Application Publication 2005/0267595 to Chen et al., which are incorporated herein by reference, describe a gastric balloon that includes a scaffold structure, one or more internal inflatable compartments within the scaffold structure, and one or more inflatable bladders formed over the space-filling compartment. The gastric balloon may be deployed transesophageally using a gastroscope, and is inflated in situ, preferably using a combination of liquid and gas inflation media.
PCT Publication WO 05/009288 and US Patent Application Publication 2005/0033331 to Burnett et al., which are incorporated herein by reference, describe techniques for facilitating intermittent and/or partial obstruction of a pyloric valve. Devices described generally include a support portion for preventing the device from passing through the pyloric valve, and a tissue engagement portion for contacting tissue adjacent the pyloric valve to obstruct the valve. Some embodiments also include a positioning member extending from the tissue engagement portion for helping position the device for obstructing the valve. A retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are described as being fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.
US Patent Application Publication 2005/0055039 to Burnett et al., which is incorporated herein by reference, describes a device for performing one or more functions in a gastrointestinal tract of a patient, which includes an anchoring member and at least one actuator, sensor, or combination of both coupled with the anchoring device. The anchoring device is adapted to maintain at least part of the device within a pyloric portion of the patient's stomach and to intermittently engage, without directly attaching to, stomach tissue. Actuators perform any suitable function, such as transmitting energy to tissue, acting as a sleeve to reduce nutrient absorption, occupying space in the stomach, eluting a drug and/or the like. Sensors may be adapted to sense any suitable patient characteristic within the patient's gastrointestinal tract, such as pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and/or hemoglobin.
The following patents and patent application publications, which are incorporated herein by reference, may be of interest:
US Patent Application Publication 2005/0228504 to Demarais
US Patent Application Publication 2005/0085923 to Levine et al.
US Patent Application Publication 2005/0192614 to Binmoeller
US Patent Application Publication 2004/0267378 to Gazi et al.
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PCT Publication WO 04/089262 to Paganon
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US Patent Application Publication 2005/0070937 to Jambor et al.
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PCT Publication WO 04/105622 to Ritchie
US Patent Application Publication 2004/088008 to Gannoe et al.
PCT Publication WO 04/014237 to Gannoe et al.
US Patent Application Publication 2004/093091 to Gannoe et al.
US Patent Application Publication 2004/059289 to Garza et al.
PCT Publication WO 03/095015 to Alverdy
European Patent Application Publication EP 1342458 to Creusy et al.
US Patent Application Publication 2003/158569 to Wazne
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The following articles, which are incorporated herein by reference, may be of interest:
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Fleischer D E et al., “A marked guidewire facilitates esophageal dilation,” Am J Gastro 84:359-61 (1989)
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